902 KAR 20:200. Tuberculosis (TB) Testing for Residents in Long-Term Care Settings

902 KAR 20:200. Tuberculosis (TB) testing for residents in long-term care settings.

Amended regulation below was copied on March7, 2016 from the Kentucky Legislative Commission Website, http://www.lrc.ky.gov/kar/902/020/205reg.htm

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CABINET FOR HEALTH AND FAMILY SERVICES

Office of Inspector General

Division of Health Care

(As Amended at ARRS, January 11, 2016)

902 KAR 20:205. Tuberculosis (TB) testing for health care workers.

RELATES TO: KRS 215.520-215.600, 216B.010-216B.131, 216B.990

STATUTORY AUTHORITY: KRS 216B.042(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to establish licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 215.590 requires a health service or health facility licensed pursuant to KRS Chapter 216B or KRS Chapter 333 to report knowledge of a person who has active tuberculosis to the local health department. This administrative regulation establishes requirements for tuberculosis (TB) testing of health care workers in health facilities or settings licensed under KRS Chapter 216B or KRS Chapter 333. These procedures are necessary to minimize the transmission of infectious tuberculosis disease among staff and patients or residents of health facilities.

Section 1. Definitions. (1) "Air changes per hour" or "ACH" means the air change rate expressed as the number of air exchange units per hour.

(2) "Airborne Infection Isolation (AII) room" means a room, formerly called a negative pressure isolation room, which is designed to maintain AII and is a single-occupancy patient-care room used to isolate persons with suspected or confirmed infectious TB disease.

(3) "BAMT conversion" means a change in the BAMT test result, on serial testing, from negative to positive over a two (2) year period.

(4) "Blood Assay for Mycobacterium tuberculosis" or "BAMT" means a diagnostic blood test that:

(a) Assesses for the presence of infection with M. tuberculosis;[and]

(b) Reports results as positive, negative, indeterminate, or borderline; and

(c)[. This test] Includes interferon-gamma (IFN-ɣ) release assays (IGRA).

(5) "Boosting" or the "booster phenomenon" means if nonspecific or remote sensitivity to tuberculin purified protein derivative (PPD) in the skin test wanes or disappears over time, subsequent tuberculin skin tests (TSTs) may restore the sensitivity.

(6) "Extrapulmonary tuberculosis" means TB disease in any part of the body other than the lungs (e.g., kidney, spine, or lymph nodes), and may include the presence of pulmonary TB or other infectious TB diseases.

(7) "Health care setting" or "health facility" means the following settings:

(a) Abortion facility;

(b) Adult day health program;

(d) Ambulatory care clinic;

(e) Ambulatory surgical center;

(f) Blood establishment;

(g) Chemical dependency treatment service;

(h) Community mental health center;

(i) Comprehensive physical rehabilitation hospital;

(j) Critical access hospital;

(k) Family care home;

(l) Freestanding birth center;

(m) Group home;

(n) Home health agency;

(o) Hospice program;

(p) Hospital;

(q) Intermediate care facility;

(r) Intermediate care facility for individuals with an intellectual disability (ICF/IID);

(s) Limited services clinic;

(t) Medical laboratory;

(u) Mobile health service;

(v) Network;

(w) Nursing facility;

(x) Nursing home;

(y) Nursing pool;

(z) Outpatient health care center;

(aa) Pain management facility;

(bb) Personal care home;

(cc) Prescribed pediatric extended care facility;

(dd) Psychiatric hospital;

(ee) Primary care center;

(ff) Private duty nursing agency;

(gg) Level I or Level II psychiatric residential treatment facility;

(hh) Rehabilitation agency;

(ii) Renal dialysis facility;

(jj) Residential hospice facility;

(kk) Rural health clinic;

(ll) Special health clinic;

(mm) Specialty intermediate care clinic;

(nn) Specialized medical technology service; or

(oo) Behavioral health services organization.

(8) "Health care workers" or "HCWs" means all paid and unpaid persons working in health care settings who have the potential for exposure to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air, and shall include:

(a) Physicians;

(b) Physician assistants;

(d) Medical assistants;

(e) Nursing assistants or nurse aides;

(f) Therapists;

(g) Technicians;

(h) Emergency medical service personnel;

(i) Dental personnel;

(j) Pharmacists;

(k) Laboratory personnel;

(l) Autopsy personnel;

(m) Students and trainees;

(n) Contractual and community-based physicians and other healthcare professionals and staff not employed by the health care facility; and

(o) Persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that may be transmitted to and from health care workers and patients or residents.

(9) "Induration" means a firm area in the skin that develops as a reaction to injected tuberculin antigen if a person has tuberculosis infection and that is measured in accordance with Section 3(2) of this administrative regulation.

(10) "Infectious tuberculosis" means pulmonary, laryngeal, endobroncheal, or tracheal TB disease or a draining TB skin lesion that has the potential to cause transmission of tuberculosis to other persons.

(11) "Latent TB infection" or "LTBI" means infection with M. tuberculosis without symptoms or signs of disease having been manifested.

(12) "Multidrug-resistant tuberculosis" or "MDR TB" means TB disease caused by M. tuberculosis organisms that are resistant to at least isoniazid (INH) and rifampin.

(13) "Nucleic Acid Amplification" or "NAA" means a laboratory method used to target and amplify a single deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) sequence usually for detecting and identifying a microorganism.

(14) "Polymerase chain reaction" or "PCR" means a system for in vitro amplification of DNA or RNA that can be used for diagnosis of infections.

(15) "Staggered tuberculosis testing" means the testing of a health care worker in or before the same month as the anniversary date of his or her date of initial employment, or testing in or before the worker’s birth month so that all health care workers do not have tuberculosis testing in the same month.

(16) "TST conversion" means a change in the result of a test for M. tuberculosis infection in which the condition is interpreted as having progressed from uninfected to infected in accordance with Section 3(4) of this administrative regulation.

(17) "Tuberculin Skin Test" or "TST" means a diagnostic aid for finding M. tuberculosis infection that:

(a) Is performed by using the intradermal (Mantoux) technique using five (5) tuberculin units of purified protein derivative (PPD); and

(b) Has results read forty-eight (48) to seventy-two (72) hours after injection and recorded in millimeters of induration.

(18) "Tuberculosis (TB) disease" means a condition caused by infection with a member of the M. tuberculosis complex that meets the descriptions established in Section 3(3) of this administrative regulation.

(19) "Tuberculosis Risk Assessment" means an initial and ongoing evaluation of the risk for LTBI or active TB disease in a particular health care worker and is performed in accordance with the provisions established in Sections 4, 5, 7, and 11 of this administrative regulation.

(20) "Two-step TST" or "two-step testing" means a series of two (2) TSTs administered seven (7) to twenty one (21) days apart and used for the baseline skin testing of persons who will receive serial TSTs, including health care workers and residents of long-term care settings, to reduce the likelihood of mistaking a boosted reaction for a new infection.

Section 2. TB Infection Control Program. (1) Each health facility shall have a written TB infection control plan that is part of an overall infection control program.

(2) The TB infection control plan shall be designed to control M. tuberculosis transmission through early detection, isolation, diagnosis, and treatment of persons with active TB disease.

(3) A hierarchy of control measures shall be used, including:

(a) Administrative controls;

(b) Environmental controls;[,] and

(4) A TB infection control plan shall include a listing of the job series of health care workers or another standardized method to describe which health care workers shall be included in the facility TB screening program.

(5) At a minimum, a health care worker shall be included in the TB screening program if the worker:

(a) Has duties that involve faceto-face contact with patients with suspected or confirmed active TB disease, including transport staff;

(b) Has the potential for exposure to M. tuberculosis through air space shared with persons with suspected or confirmed active TB disease of the respiratory system;

(d) Has duties that have the potential for exposure to the environment of care of persons with suspected or confirmed active TB disease; or

(e) Performs other tasks or procedures which may generate infectious aerosol droplet nuclei in which the worker has or may have exposure to TB disease.

(6) A facility may voluntarily include additional or all health care workers in the TB screening program based upon:

(a) TB incidence (local or regional);

(b) Other TB risk factors;

(d) Patient safety strategies;

(e) Risk management strategies; or

(f) Any other factors.

Section 3. Tuberculosis Testing Requirements for TSTs. (1) Two-step testing shall be used to distinguish new infections from boosted reactions in infection-control surveillance programs.

(2)(a) A TST shall be performed by:

1. A physician;

2. An advanced practice registered nurse;

3. A physician assistant;

4. A registered nurse;[,] or

5. A pharmacist.

(b) A licensed practical nurse under the supervision of a registered nurse may perform a TST.

(3) Induration Measurements.

(a) The diameter of the firm area shall be measured transversely (i.e., perpendicularly) to the long axis of the forearm to the nearest millimeter to gauge the degree of reaction, and the result shall be recorded in millimeters.

(b) The diameter of the firm area shall not be measured along the long axis of the forearm.

(c) A reaction of ten (10) millimeters or more of induration, if the TST result is interpreted as positive, shall be considered highly indicative of tuberculosis infection in a health care setting.

(d) A reaction of five (5) millimeters to nine (9) millimeters of induration may be significant in certain individuals with risk factors described in Section 4(3) of this administrative regulation for rapid progression to active tuberculosis disease if infected.

(4) Tuberculosis (TB) disease.

(a) A person shall be diagnosed as having tuberculosis (TB) disease if the infection has progressed to causing clinical (manifesting signs or symptoms) or subclinical (early stage of disease in which signs or symptoms are not present, but other indications of disease activity are present, including radiographic abnormalities) illness.

1. Tuberculosis that is found in the lungs shall be[is] called pulmonary TB and may be infectious.

2. Extrapulmonary disease (occurring at a body site outside the lungs) may be infectious in rare circumstances.

(b) If the only clinical finding is specific chest radiographic abnormalities, the condition is termed "inactive TB" and shall be differentiated from active TB disease, which is accompanied by symptoms or other indications of disease activity, including the ability to culture reproducing TB organisms from respiratory secretions or a specific chest radiographic finding.

(5)(a) A TST conversion shall have occurred if the size of the measured TST induration increases by ten (10) millimeters or more during a two (2) year period in a health care worker with a:

1. Documented baseline two-step TST result measured as zero (0); or

2. Previous follow-up screening TST result with induration measured as one (1) millimeter to nine (9) millimeters and interpreted as negative during serial testing.

(b) A TST conversion shall be presumptive evidence of new M. tuberculosis infection and poses an increased risk for progression to TB disease.

Section 4. TB Risk Assessment and Tuberculin Skin Tests or BAMTs for Health Care Workers on Initial Employment. (1) Risk Assessment.

(a) To perform a TB Risk Assessment, a questionnaire shall be used and the following factors shall be assessed:

1. The clinical symptoms of active TB disease;

2. Events and behaviors that increase the risk for exposure to M. tuberculosis and the risk of acquiring LTBI; and

3. Medical risk factors that increase the risk for a health care worker with LTBI to develop active TB disease.

(b) A TB Risk Assessment questionnaire may be obtained from the Kentucky Department for Public Health (published online at http://chfs.ky.gov/dph/epi/tb.htm) or from a national medical or public health organization, including the American Academy of Pediatrics or the Centers for Disease Control and Prevention.

(c) TB Risk Assessment questions shall be on a facility-approved form or incorporated into the facility’s medical history forms or into forms or other features of the facility’s electronic medical record systems.

(2) Exclusion of Health Care Workers from Tuberculin Skin Tests or BAMTs Upon Initial Employment in a Health Facility. A TST or BAMT shall not be required at the time of initial employment if the health care worker provided medical documentation for one (1) of the following as part of a TB Risk Assessment:

(a) A prior TST of ten (10) millimeters or more of induration if the TST result was interpreted as positive;

(b) A prior TST of five (5) millimeters to nine (9) millimeters of induration if the health care worker has a medical reason as described in subsection (3) of this section for his or her TST result to be interpreted as positive;

(d) A TST conversion;

(e) A BAMT conversion;

(f) Current receipt or completion of[The health care worker is currently receiving or has completed] treatment for LTBI with one (1) of the treatment regimens recommended by the Centers for Disease Control and Prevention;

(g) Completion of[The health care worker has completed] a course of multiple-drug therapy for active TB disease recommended by the Centers for Disease Control and Prevention; or

(h)[The health care worker provided medical documentation that he or she has had] A TST or BAMT within three (3) months prior to initial employment at the facility and previous participation[has previously been] in a serial testing program at another medical facility or health care setting.

(3) A medical reason for a health care worker’s TST result of five (5) millimeters to nine (9) millimeters of induration to be interpreted as positive may include:

(a) HIV-infection;

(b) Immunosuppression from disease or medications;